Association of the Stroke Ready Community-Based Participatory Research Intervention With Incidence of Acute Stroke Thrombolysis in Flint, Michigan

Key Points Question Is optimizing acute stroke emergency department care coupled with a community stroke preparedness intervention associated with increased thrombolysis treatment rates in a predominantly Black community? Findings In this nonrandomized controlled trial of the Stroke Ready intervention, which involved 5970 adults, optimizing emergency department care was associated with an increase in stroke thrombolysis treatment rates over time in the community. Meaning These findings suggest that implementation science strategies in low-resource hospitals may be a good way to increase stroke thrombolysis treatments and promote health equity.

Stroke Ready is a health behavior theory-based, multi-level intervention, designed to increase acute stroke 9 treatment in Flint. The aims of the grant are: 10 11 Specific Aim 1: To adapt and expand our CBPR-developed, theory-based, Stroke Ready pilot community 12 intervention and implement a hospital-based intervention to optimize acute stroke care in an urban safety-net, 13 hospital. 14 Specific Aim 2: To increase acute stroke treatment rates in Flint, Michigan through a two-pronged approach of 15 hospital and community level interventions. 16 Specific Aim 3: To inform future CBPR acute stroke treatment interventions by exploring both the relative 17 importance of community and hospital interventions and the efficacy of the intervention on processes 18 mediating the outcome. 19 Our hospital-level intervention aims to optimize acute stroke hospital care in a safety net ED. This has been 20 approved under HUM00112536. Meanwhile, the community intervention seeks to increase acute stroke 21 treatment (by decreasing pre-hospital delay). Ultimately, by exploring the effects of the community and hospital 22 interventions individually and together, Stroke Ready can serve as a model for other at risk communities to 23 increase acute stroke treatment. We will also estimate the cost effectiveness which is vital as hospitals and 24 communities determine how to use their resources and meet the requirement of stroke centers to provide 25 community education. This application is for the community-level intervention. 26 27 Background 28 Post-stroke disability is common, costly and projected to increase. Most of the more than 7 million stroke 29 survivors in the US have disability. Acute stroke treatments, which include intravenous tissue plasminogen 30 activator (tPA) and intra-arterial treatment, substantially reduce post-stroke disability but are administered to 31 less than 5% of stroke patients. These treatments are particularly underutilized in Flint, Michigan, where the 32 rate of acute stroke treatment is half the national rate. In fact, Flint has the lowest treatment rate of any region 33 of its size in the entire US, which only exacerbates the existing health disparities in this predominantly African-34 American community. The low treatment rates of the Flint community are illustrative of racial disparities in 35 stroke -African Americans have a higher incidence of stroke, receive acute stroke treatments less often and 36 experience greater post-stroke disability than non-Hispanic whites. These inequities can be at least partially 37 addressed with interventions to increase acute stroke treatment rates; but practical, cost efficient and 38 sustainable interventions are lacking.

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Acute stroke treatments are administered in the Emergency Department and are both rigidly time limited and 41 highly time sensitive. Earlier treatment means a greater chance of stroke recovery ("Time is brain"). One of the 42 main reasons for acute stroke treatment underutilization is pre-hospital delay -patients arrive to the hospital 43 too late to receive the treatment. One strategy to reduce pre-hospital delay is to focus on stroke preparedness 44 (ability to recognize acute stroke symptoms and call 911 immediately) through community behavioral 45 interventions. Over the past 7 years, the research teams composed of researchers from the University of 46 Michigan and community partners from Flint, increased stroke preparedness in Flint through our Stroke Ready 47 pilot intervention (HUM00098718). In addition to pre-hospital delays, hospital delays also contribute to Flint's 48 low acute stroke treatment rates. When stroke patients arrive to the hospital, a multistep process occurs to 49 determine whether the patient is eligible for acute stroke treatments and to rapidly administer the treatment. 50 Hospitals are known to vary widely in their abilities to execute these complex treatment pathways and thus, 51 optimal interventions to improve treatment rates should target both the community and the hospital.  Inclusion/ Exclusion criteria (Stroke Ready workshops) 108 Workshops will be open to the public. While our primary outcome will observe Flint-based stroke treatment 109 rates, stroke preparedness is a global public health message applicable to most people; therefore, participants 110 will not be excluded if they live outside the city limits. Similarly, the workshops are designed for English-111 speaking adults; however, non-English speaking people will not be excluded. The Stroke Ready workshop 112 should not be harmful to children as it is adapted from material delivered to adults and youth in the pilot study 113 (HUM00098718). Thus, if adults choose to bring their children, they will be accommodated in the workshops.

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Stroke Ready recruitment (Stroke Ready Workshops) 116 The research team and Stroke Ready peer-leaders will work together to recruit organizations and participants 117 for the Stroke Ready workshops through recruitment announcements, flyers, internet platforms, and word-of-118 mouth. Since Flint is naturally divided into 4 quadrants the study team will select each quadrant for 119 implementation and then for about the next 6 months they will focus their workshop recruitment efforts and 120 material dissemination on the selected quadrant of the city. However, given the commitment to CBPR the 121 quadrant implementation is preferred but we would not forego a workshop in a quadrant that we are not 122 focusing on at the time if requested. During this time the research team and community partners, including 123 peer leaders, will work together to implement the Stroke Ready workshops and distribute educational posters 124 and materials. At the end of about six months, the materials will remain in the quadrant and efforts will shift to 125 the next quadrant for recruitment and workshop delivery. 126 127

Pre-Intervention
To overcome challenges of recruiting racial minorities, low-income individuals, and other disadvantaged 128 populations due to lack of transportation, childcare, inconvenient hours, etc., the research team designed 129 the workshops such that participants can participate at their convenience. The workshops are voluntary and 130 will be delivered by peer-leaders at locations during times that are convenient for the community (e.g. after 131 church services, during lunch breaks). Additional factors that facilitate program recruitment and 132 participation are: 1) the workshops, as well as all Stroke Ready materials and activities, are free and have 133 no more than minimal risk; 2) recruitment materials and intervention components were created by the 134 community for the community; 3) the research team has gained support of local leadership and community 135 members with strong ties in the Flint community; 4) children will be allowed to attend (HUM00098718).

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Given the nature of the other community intervention components (i.e. educational posters for which 138 recruitment is not applicable), the Stroke Ready workshop is the only component for which the research 139 team and community partners will actively recruit, i.e. advertising its availability to the community. With 140 regard to the music video, educational print materials, internet platforms, and mailers, there is no need to 141 actively recruit as these interventions will be distributed and/ or implemented among the community as the 142 others parts of the public health stroke preparedness message. With regard to workshop retention and 143 compensation: Workshop participants will not be compensated for attending as this is a free, educational 144 workshop on stroke preparedness. Depending on the location, participants may receive small tokens such 145 as Stroke Ready pens of food. The workshop participant is free to leave the workshop at any time. The 146 research team will oversee the activities related to workshop participant recruitment to track the campaign's 147 reach and resources, and workshop delivery processes to assess workshop fidelity.

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Stroke Ready Peer Leader 150 To build community capacity as well as to increase the uptake and relevance of the workshops in the 151 community, peer leaders will be hired from the Flint community as much as possible for our community based 152 intervention. We will recruit about 8-16 peer leaders to start but recognize there may be turnover during the 153 intervention or high demand for additional workshops; therefore, the research team may need to recruit 154 additional peer leaders during the workshop delivery phase. We will pay about $15 per hour for recruitment 155 and delivering the workshops that include the minimum required attendees. We anticipate that some the peer 156 leaders may be UM-Ann Arbor or UM-Flint students who prefer class credit to payment. If this were the case, 157 we would work with the institution to facilitate credit attainment. Peer leaders will be cross-trained so that if one 158 is unable to show up on the day of the workshop another peer leader will be able to facilitate the group. Peer 159 leaders will be strongly encouraged workshops every week for the duration of the project.

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The peer-leaders are not participants, but facilitators of the workshop. They will facilitate the workshop 162 discussion and activities through use of a peer leader workshop facilitation guide and pre-recorded script. The 163 research team will confirm peer leader workshop facilitation readiness by assessing Stroke Ready knowledge 164 and Stroke Ready practice skill-set during the peer leader training session required by each peer leader before 165 facilitating Stroke Ready workshops. Peer leaders will be evaluated on the materials to determine whether they 166 have adequate knowledge to administer the workshop as well as the skills needed to facilitate the discussion 167 and activities. The research team will train peer leaders in public presentation strategies, stroke educational 168 materials, and other practices to build and strengthen a skillset to facilitate an open environment for learning 169 and discussion. The research team will be available during business hours and as much as possible outside of 170 business hours for any questions or concerns.

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Stroke Ready Peer Leader Training 173 The Stroke Ready research team will provide workshop facilitation training to Stroke Ready peer leaders. The 174 primarily face-to-face training will take approximately 8-10 hours (1-2 training sessions) and will be conducted 175 in Flint, Michigan at a location and time agreed upon the research team and peer leaders. Subsequently, peer 176 leaders will attain the Stroke Ready Peer Leader training completion certificate before the start of facilitating 177 workshops in the community.

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Peer leaders will be paid for completing the training. Upon training completion each peer leader will receive a 180 trainer's guide, which provides a step-by-step teaching guide and peer leader script for the workshops, a tPA 181 demonstration kit, and the instructions for how to set up and use all workshop materials. All materials have 182 been specifically tailored to the Flint community. At any point during the delivery of the workshops phase, the 183 research team may determine that the peer leader needs additional training to fulfil the minimum requirements 184 for the role. When additional training is needed, the research team will provide tailored training exercises and 185 materials to the peer leader. The research team may not pay the peer leader for re-training. The research team 186 may ask that the peer leader not facilitate additional workshops until they have completed the necessary 187 retraining. Training and retraining activities will be tracked by the research team.

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Intervention Components 190 The community intervention components focus on public health education emphasizing the significance of 191 stroke preparedness. Primary Stroke Ready components will consist of peer facilitated educational workshops, 192 a music video adapted and expanded from the pilot (HUM98718), a mass media campaign including print 193 materials (e.g. posters, brochure), health promotion mailers, radio/TV public health service announcements, 194 and the Stroke Ready website and Facebook page ( Table 2). The community intervention components are 195 purely public health education piloted in (HUM00098718) which includes stroke knowledge and stroke 196 preparedness education.

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We have submitted scripts/text for the stroke preparedness materials. These items are being edited/produced 199 currently. We plan to submit to the IRBMED copies (or the equivalent) of the final materials when available. 200 These will be complete with graphics, music, etc. We reviewed the content, graphics, and music with the 201 community to assure appropriateness of content and cultural sensitivity. No participant is forced to watch or 202 read any of the materials. They are provided to the community for them to use as they wish. Peer leaders will be hired from the community and trained to deliver the Stroke Ready workshop. The 209 workshops, consisting of education related to stroke preparedness such as, a stroke narrative, stroke happens 210 in Flint, good news: stroke is treatable, what is stroke, FAST signs, a tPA demonstration, timing is everything: 211 call 911, Stroke Ready action plan, and Stroke Ready music video or audio, will last approximately 60 minutes. 212 Workshop materials that the peer-leaders will use to educate include a workbook, PowerPoint or flip 213 chart/easel (pending availability of multi-media equipment per location), a role play script, a tPA demonstration, 214 and an adapted music video for stroke education and preparedness. Interactive activities will include a role 215 play, group discussions, and self-learning assessments. Each workshop will include education and 216 behavioral/social learning strategies to which all educational materials have been geared. Participants may be 217 given nominal gifts, such as a pens with the Stroke Ready logo. 218 For all materials and activities, if issues arise e.g., time constraints, the peer-leader may exclude some portions 219 or alter formatting/order of certain sections in the workshop. These changes may be required in response to 220 participant feedback or time constraints. Additionally, graphics may be slightly altered to enhance the 221 professional, finished look of the product. None of the content of the materials should significantly change after 222 IRB approval.

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The peer-led workshop has been adapted so that it may be tailored in both length and interactive content, 225 while maintaining integrity to the core public health message-stroke preparedness. These adaptations make 226 the workshops more conducive to wide-spread implementation and allow for greater flexibility in provision of 227 workshops given the needs and time-requirements of community organizations and community members. It is 228 expected that about 150 workshops will be delivered throughout the 6-month time period per quadrant (x 4 229 quadrants). 230 While the full version of the workshop is the preferred version for delivery of the education, our community 231 advisory board suggested a shorter option that may be more appropriate for the workplace or after established 232 group gatherings. Thus, a 30-minute version of the workshop is an option. This abbreviated version of the 233 workshop foregoes most of the interactive components such as the group discussion and role play. 234 Media format: (Pending availability of multi-media equipment per workshop location) Delivery of the 235 intervention will be via a PowerPoint presentation with content from the workbook, audio recorded portions 236 covering for core components, and music video. 237 Non-Media format: A flip chart/easel with content from the workbook will be used for delivery. Music from 238 Stroke Ready video will be played on audio only, however peer leader will be able to facilitate participants 239 viewing of the Stroke Ready music video on their personal smartphones, as well as directing participants to 240 view it on the Stroke Ready website or Facebook page. 241 The workshop includes a workbook providing Flint-tailored stroke preparedness education and an audio 242 recording to facilitate the content, as well as peer-led interactive activities. The core components of the Stroke 243 Ready intervention include a stroke narrative, stroke happens in Flint, good news: stroke is treatable, what is 244 stroke, FAST signs, a tPA demonstration, timing is everything: call 911, Stroke Ready action plan, and Stroke 245 Ready music video or audio. 246 If a peer-led workshop is not feasible for a group, the study team may provide a shortened, non-peer-led 247 version which includes core components of stroke preparedness education, brochures, and action plan, and 248 the music video or instructions for accessing the music video. This "workshop" adaptation is about 10 -15 249 minutes long and it is expected to be a non-peer-led intervention to be disseminated throughout the 6-month 250 time period per quadrant (x 4 quadrants). 251

Component 2: Stroke Ready Music Video 252
The Stroke Ready music video, an integral component of the Stroke Ready community intervention, was 253 developed during the Stroke ready pilot (HUM00098718), incorporates the National Stroke Association's FAST 254 stroke symptoms pneumonic (e.g. F-facial droop, A-arm weakness, S-slurred speech, T-time to call 911) 255 into an original gospel-based music score and video. There is also a strong focus on self-efficacy with the 256 video asking viewers to participate in demonstrating stroke signs. 29 There will be a full length and shorter 257 version.

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The Stroke Ready music video will be available to access on the Stroke Ready website and Facebook page 260 and may be played during in the workshops pending media capabilities. Also, peer leaders will be asked to 261 disseminate the Stroke Ready website address via their email, Facebook, and text messaging contacts. The 262 link will also be placed on print materials. 263 264 Component 3: Print media -Posters and Brochures 265 The Stroke Ready program will include a print media campaign with posters and brochures to be dispersed by 266 the research team per quadrant for display and distribution by local organizations. All print materials were 267 developed with community input and feedback through focus groups and interviews with community members 268 (HUM00130902

Component 4: Broadcast Media -TV and Radio public service announcements (PSAs) 274
An about 60-second version of the music video and audio only version will be created for use as TV and radio 275 PSAs. There will be two additional PSAs including stroke preparedness messages the research team 276 developed using theory based health behavior change methods and reviewed by the community PI. The citywide intervention includes mailers printed in and distributed throughout the city of Flint on the per 286 quadrant schedule. The mailer may include a Stroke Ready magnet, brochure, action plan, and information 287 letter about the Stroke Ready campaign and where to find more information or a local stroke ready event. 288 289 290 Stroke Ready Fidelity Assessment, Process Evaluation, Outcomes 291 Fidelity assessment and process evaluation measures the extent to which an innovation and its activities are 292 implemented as intended. As such, the research team will conduct fidelity assessments and collect process 293 measures to track any changes or adaptations made to a Stroke Ready workshop and Stroke Ready campaign 294 upon implementation. The Stroke Ready campaign will also collect primary and secondary outcomes (Table 4).

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Fidelity Assessment 297 The research team will randomly select a proportion of workshops to observe for fidelity assessments to 298 assess whether the workshop is being conducted as intended. Other fidelity measures the research team will 299 collect include exposure of dose, quality of delivery, participant responsiveness, program differentiation, and 300 intervention complexity. These assessments are to measure the degree to which teachers or staff are able to 301 use the instructional practices as intended and facilitate the workshop as intended.

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Aspects of fidelity the research team will measure (See Appendix A) include: dose delivered -as measured by 304 workshop duration and content delivered; dose received -as measured by post-intervention survey to 305 determine exposure to all intended activities per workshop type & satisfaction; quality of delivery -as 306 measured by facilitator's utilization of techniques prescribed by the program (use of facilitator's guide, use of 307 audio/PowerPoint, appropriate facilitation of activities); reach -as measured by attendance; participant 308 responsiveness -as measured by post-intervention survey to identify participant interest in activities and 309 perceived usefulness of information; program differentiation -as measured through a post-intervention survey 310 to identify which workshop components participants liked most; intervention complexity -as measured through 311 tracking peer facilitator's attendance at initial training session and completion of refresher training if it has been 312 longer than 6 months since the facilitator last delivered a workshop (which will be available as an online 313 training module); and context -as measured through observation field notes of aspects of environment that 314 may influence intervention implementation or study outcomes 315

Stroke Ready Process Evaluation 316
The research team will collect Stroke Ready community-level intervention and uptake process measures 317 ( Table 3). The community-level intervention uptake will be measured with questions in the community surveys, 318 Speak to your Health and Flint Area Study, regarding exposure to and satisfaction with the posters, flyers, 319 workbook and music video (See Appendix 320 B). Uptake of the Stroke Ready video and 321 internet materials will be measured by 322 counts of internet hits from internet protocol 323 (IP) addresses of video viewers from within 324 Flint. This will be tabulated by linking to a 325 database that maps IP address to physical 326 locations. Satisfaction with the Stroke 327 Ready workshop will be included in the 328 participant survey (Appendix C). 329

Cost-effectiveness Analysis 330
The research team will assess the cost 331 effectiveness of the overall Stroke Ready 332 Program. Cost-effectiveness will be 333 estimated for two intervention scenarios: 334 Stroke Ready delivery and Stroke Ready 335 development and delivery. This will inform 336 the value of taking the Stroke Ready 337 Intervention, "out of the box" and delivering it in a novel context and to separately assess the cost of 338 developing and delivering a similar intervention in a novel context.

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Cost inputs to the models will be carefully recorded throughout the project. For development costs, we will use 341 budgets from the Stroke Ready pilot to estimate the cost of developing all materials used in this proposal -342 music video, workbooks, workshop content and print media. Delivery costs will be tracked with each phase of 343 the Stroke Ready program. All Stroke Ready material expenditures (e.g. print media production, website 344 maintenance) will be tracked, and as appropriate, assigned to either the hospital or community portion of the 345 intervention. To track personnel time for the workshops, we will maintain a spreadsheet and update it after 346 every Stroke Ready workshop with the number of individuals involved, including participants. Each hour spent 347 on the grant will be mapped to costs by assigning appropriate job titles and then mapping hourly wages for that 348 title to Bureau of Labor Statistics Survey wage survey data by profession. 30 By summing work time costs and 349 material costs, we will be able to estimate the total costs of the overall intervention and the hospital and 350 community interventions separately. We will then separately estimate total quality adjusted life years (QALYs) 351 gained by the Stroke Ready program (and separately for the hospital and community interventions) by applying 352 the primary outcome treatment effect size to the total hospitalized population (i.e. 2.2% increase in treatment 353 rates * 500 strokes = 11 additional patients treated) and estimated QALY gain using published stroke cost 354 effectiveness models. 31, 32 Estimated hospital and community effect sizes will be obtained from our secondary 355 analysis assessing intervention component efficacy. The age distribution of patients who receive treatment via 356 the intervention will be obtained from the overall Flint stroke population. By using repeated bootstrap samples 357 from this population and repeatedly running the model we will estimate 95% credible intervals on the QALY 358 To both fully evaluate the Stroke Ready program and inform future interventions, we will measure the primary 364 outcome and a number of secondary outcomes (Table 4); the process outcomes (intervention dissemination 365 and reach) was described above. By measuring each step of the delivery process for the Stroke Ready 366 campaign intervention we will collect secondary outcomes we hope will inform future CBPR stroke 367 preparedness campaigns for community-level health education acute stroke treatment interventions. 368 369 370

Ascertainment of Outcomes 371
The primary outcome will be measured from hospital EMR, billing data and/or from the Get With the Guidelines 372 stroke registry data. Data will be separately received from the three hospitals in Flint (received letters of 373 support and UFA in progress), which together account for 95% of all stroke treatments in Flint residents. The 374 study population will be patients with a primary diagnosis of ischemic stroke using ICD-9 codes and/ or ICD-10 375 codes 33, 34 The primary outcome will be any thrombolysis which includes both IV tPA (MS-DRG 61-63 or ICD-9 376 procedure code 99.10), intra-artery treatment (MS-DRG 21-23 or CPT codes 37184-6, 37201, 75896) and the 377 combination identified by ICD-9 and ICD-10 codes. 3 The research team will attempt to obtain data from 2010 378 to 2021 if available to account for linear trends. 379 380 The community secondary outcomes are the number of stroke patients who arrive by ambulance, onset to door 381 time, and door to needle time. Data will be obtained from the EMR or GWTG data of the three hospitals in Flint.

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Additional community level secondary outcomes will be measured with community surveys. The community 383 survey, Speak to Your Health, is a biennial, geo-coded survey that has been designed and administered by the 384 Flint community, Genesee County Health Department since 2003. 35 We added questions from the Stroke 385 Ready pilot (HUM00098718) (including stroke attitude, self-efficacy, social norms, and written stroke 386 preparedness vignettes) to this community survey (see Appendix B) that was administered in 2015/2017 and 387 will continue in 2019 and possibly 2021. The research team may add stroke education exposure questions to 388 the 2019 and 2021 STYH surveys (see section 29 of IRB application-exposure questions). These additions, 389 along with the original questions, will assess community level change in response to the Stroke Ready 390 program; as well as exposure to local stroke education. Additionally, these same questions will be added to the 391 Flint Area Study. This is a face to face interview of Flint residents. The survey data will be de-identified. STYH 392 and FASt surveys are publically accessible. 393

Secondary Outcomes (Individual Level-Workshop Participants)
Increase workshop Satisfaction Satisfaction, Self-efficacy Individual survey During workshop 394

Outcome analyses 395
Primary Analysis: Determine impact of Stroke Ready Campaign on acute stroke treatment rates in Flint 396 The primary analysis will be an interrupted time series comparison of acute stroke treatment rates in the three 397 Flint hospitals. The pre-intervention period will be defined using EMR data prior to the start of the roll out of the 398 community intervention. All patients admitted with a primary diagnosis of ischemic stroke in both the pre-399 intervention and intervention periods will be included in the primary analysis. Note: process measures 400 evaluating the Stroke Ready campaign (quadrant crossover or music video view IP address) will not be linked 401 to any obtained PHI. Logistic regression will be used to estimate the overall intervention efficacy (indicator 402 variable) in a model predicting receipt of acute stroke treatment (binary variable). If a temporal trend exists in 403 the pre-intervention period, we will adjust for the month since the start of the pre-period as a fixed effect while 404 accounting for clustering at the hospital level. To maximize statistical power, both interventions (hospital-405 HUM00112536 and all community quadrants-this current protocol) will be parameterized with a single variable. 406 With this approach, statistical power for the primary analysis will be more than adequate. Using hospital 407 administrative and Medicare data, we estimate that at least 480 strokes per year will occur at the 3 Flint 408 hospitals for a total of at least 1,440 strokes in the pre period and 1,800 in the post-period. Assuming a 409 doubling in treatment rates (pre-intervention Medicare treatment rate 2.2%), 37 we will have over 90% power to 410 detect this difference considering a two-sample binomial difference in proportions. This estimate is consistent 411 with prior simulation work based on ARIMA analyses (effect size of 1.0 (pre-intervention monthly treatment rate 412 = 2.2%, standard deviation = 2.1, predicted post-intervention treatment rate 4.3%, auto-correlation=0.3). 38 413 Secondary Analyses: Regional Comparisons and Quadrant-based Analyses to Enhance Causal Inference 414 Secondary analyses will explore the extent that such confounding may influence the primary analysis and 415 enhance the ability to draw causal inferences from the primary analysis. First, we will repeat the primary 416 analysis with a concurrent control group consisting of other large Michigan metropolitan regions (regional 417 control model) where African-Americans make up more than 25% of the population (Detroit, Saginaw, 418 Muskegon, Benton Harbor). This analysis will control for regional effects that may lead to increased treatment 419 rates that occur simultaneously with our intervention in Flint using data from the Michigan State Inpatient 420 Database (SID), 39 which collects deidentified data on all acute care hospitalizations in the state of Michigan 421 within a given year. Second, by delivering the intervention sequentially to geographic quadrants within Flint, we 422 will explore whether increases in acute treatment rates parallel the geographic pattern of intervention roll out 423 (geographic model). Specifically, each stroke patient in Flint will be geocoded to one of the four intervention 424 quadrants using EMR data and a geocoding interface. Our primary analysis will then be repeated by modifying 425 the intervention indicator variable to represent whether the intervention was active in the patient's geographic 426 quadrant at the time of intervention. 427

Exploratory Analyses: Efficacy of Program Components and Temporal Patterns to Inform Future Interventions 428
To inform future interventions, the research team will perform a series of hypothesis-generating analyses to 429 inform which elements of the program were most effective and the temporal properties of the program. Due to 430 power concerns, our primary analysis does not consider the difference between the hospital and community 431 effects. Thus, we will first estimate the proportion of the change in the acute stroke treatment rate attributable 432 to the hospital-based intervention vs. the community-based intervention by repeating our geographic model 433 including an indicator variable representing the time period of the hospital intervention as well as a community 434 interaction term. In this way, we will be able to explore whether the Stroke Ready hospital or community based 435 intervention was most efficacious and whether there was synergy between the interventions. Using simulation 436 analyses, we estimate that there will be 70% power to find a doubling at the community level, 55% power to 437 find a doubling at the hospital level and 21% power to find a doubling through a community-hospital interaction. 438 Because this power is inadequate for a hypothesis-testing evaluation, we have specified this analysis as an 439 exploratory analysis whose purpose is enhance our understanding of the importance of intervention elements 440 and to inform future interventions. Second, we will determine the temporal properties of the Stroke Ready 441 intervention by adding a linear slope term and exploring quadratic terms in our geographic model to estimate 442 the time delay between intervention and changes in treatment rates and whether treatment rates level off or 443 decline as the intervention persists into its latter years. Finally, a strength of our data collection approach is that 444 we will be able to inexpensively assess the sustainability of intervention effect using Michigan SID data years 445 after the intervention is completed without needing to perform additional data collection. Together, such 446 analyses will determine the sustainability of the intervention and inform future interventions. 447 448

Exploratory analyses: Secondary Outcomes and Exploratory Outcome analyses 449
Analyzing Secondary Outcomes and Process Measures 450 Changes in the proportion of patients arriving by ambulance over time will be assessed using logistic 451 regression with an indicator variable representing the intervention period. Changes in the time from ED 452 presentation to acute stroke treatment and door to treatment will be explored using linear regression with a 453 similar indicator variable representing the intervention period. Second, changes in secondary outcomes 454 measured with the community survey across intervention waves will be assessed with ordinal logistic 455 regression (Likert-based outcomes) or chi-squared tests (binary outcomes) with indicator variables 456 representing the survey wave. Process measures will be summarized with descriptive statistics, as pre-457 intervention values will be either unmeasurable or unintelligible, formal statistical comparisons will not be 458 performed.

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Human subjects 461 Protection of Human Subjects 462 Stroke Ready is a community-level stroke preparedness public health education campaign in Flint, Michigan. 463 The PIs and other research team members take human subject protection extremely seriously.

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We will use hospital data that could allow for identification of individuals (EMR address) thus we seek IRB 466 approval as a "Standard, non-exempt, research project". Conversely, the majority of the remainder of the 467 project should be considered a public health education and promotion campaign and thus fall out of regulatory 468 oversight. Likewise, the research team is not collecting pre/post data on the educational activities or 469 promotional materials adapted for the campaign; the original materials and content previously underwent a 470 pre/posttest design (HUM00098718). The current materials and activities include the components in Table 2  471 and is the citywide public health stroke preparedness education portion of this study. The Stroke Ready 472 workshop is free and open to public; and the workshop fidelity assessment is observation in nature. The 473 research team will collect outcome and process measures (Tables 3 and 4) on the remainder of the campaign 474 components: music video, PSAs, print materials, internet platform; the research team does not intend to link 475 any of the secondary and process measures collected to the EMR data (primary outcomes).

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Human Subjects Involvement, Characteristics and Design 478 The primary outcome of the research portion of the Stroke Ready program is to assess acute stroke treatment 479 rates from the three Flint hospitals, Hurley Medical Center, McLaren-Flint and Genesys hospital, before and 480 after a citywide, community-based public health education and promotion campaign. One way to do this is to 481 decrease pre-hospital delay by increasing the proportion of stroke patients who arrive to the hospital via 482 ambulance. Thus, public health education is provided to the Flint community on stroke warning signs and 483 treatment availability via the Stroke Ready campaign. There are no exclusion criteria for the Stroke Ready 484 materials or activities as community members can choose whether they wish to engage in the active (e.g. 485 workshop) or passive (e.g. poster) components of Stroke Ready. The education is no more than minimal risk 486 and the content is readily available stroke preparedness knowledge. All data, including primary and secondary 487 outcomes, will be collected and protected by the research team. We will protect PHI with all our efforts. Since 488 the hospital EMR data is PHI, this portion of the project will require a HIPAA authorization waiver.

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Sources of Data 491 De-Identified 492 The community surveys, Speak to Your Health and the Flint Area Study, are publically available and 493 deidentified. The Michigan State Inpatient Database (SID), which collects data on all acute care 494 hospitalizations in the state of Michigan within a given year is also deidentified. Neither the workshop 495 satisfaction survey nor the fidelity assessment will not include personal identifiers.

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Identified 498 Hospital data will be obtained from the Flint area hospitals. Data will include basic demographics, treatments, 499 stroke process measures, comorbidities, and outcomes of stroke patients. This data will include identifiable 500 information in the form of addresses in order to map the stroke event from Flint into one of the four Stroke 501 Ready quadrants. We expect some of this data to come from the EMR, billing records and Get With the 502 Guidelines Stroke. We are working with each hospital to establish the optimal approach to obtaining the 503 required data. 504 505 Additionally, a process measure is the number of views of the stroke ready music video. This will be assessed 506 by the number of internet hits from within Flint via internet protocol (IP) addresses. The only use of this data is 507 to assess the whether or not the video was viewed by and for the community it was untended. 508 509 Our community partners and peer-leaders will work with the research team to schedule workshop location and 510 time convenient for the participants, peer leaders, and community partner(s). For purposes of tracking 511 quadrant crossover, i.e. assess whether the workshop participant lives within the quadrant for which it was 512 intended, the research team will collect participant address without any other identifiers, e.g. full name. The 513 addresses will not be used to track or identify workshop participants, and the information will not be shared 514 with members outside the research group. The address can be destroyed once the research team records 515 within-quadrant workshop participation status. The research team or peer leaders may provide a courtesy 516 reminder call several days before the workshop. 517 518 All paper data will be held strictly confidential in locked facilities and password protected computers/databases, 519 only accessible by necessary members of the research team. All identifiable data will be stored on the secure 520 and UMHS approved cloud storage, M-Box. The only researchers with access to the identifiable information in 521 M-Box will be Drs. Skolarus, Burke and Feng. A deidentified dataset will be created from the identifiable data 522 and the only researcher with access to this PHI link will be Drs. Skolarus, Burke and Feng. After developing 523 de-identified datasets in the enclave environment, limited analytic datasets will be used for analysis. For all 524 identifiable data collected, the research team will not use them to personally identify a Stroke Ready workshop 525 participant, stroke patient, or Stroke Ready video viewer. 526 Potential Risks 527 The potential risk is possible disclosure of confidential personal health information. This risk is extremely low 528 since the data will be stored on a secure non-networked computer and password protected. All data for 529 analysis will be completely de-identified. 530 531 Physical risks: We do not anticipate our intervention will induce physical risks as it is all based on educational 532 materials. 533 534 Psychological risks: We do not anticipate our intervention will induce psychological risks as we provide positive 535 messages. We are not collecting sensitive health information that could lead to psychological harm if disclosed 536 to unauthorized individuals. 537 538 Financial risks: We do not anticipate any financial burden all Stroke Ready education and activities are free to 539 the public. 540 541 Legal risks: We do not anticipate that our research protocol will induce any additional legal risks. 542 543 Stroke Ready Workshop and Materials 544 The Stroke Ready workshop is community-based education with no more than minimal risk, participants will 545 not be consented to observe or participant in the workshops. 546 547 Moreover, individuals who interact with the other educational components (print media campaign, mailing, 548 video/ PSAs, workbook, website) will not be considered research participants and thus will not be consented as 549 data will not be systematically collected for stroke preparedness effectiveness in a pre/posttest analysis. This 550 was accomplished in the pilot (HUM0098718). They will receive the educational components of the intervention 551 but no data will be collected. The identity of the subject will not be able to be readily ascertained by the 552 investigator or associated with the information. 553 554 Regarding identifiable data, we will request a HIPAA authorization waiver through the University of Michigan 555 IRB and Flint hospital IRBs for the EMR. The research is not feasible without the waiver. The only patient 556 identifier is address. In order to obtain HIPAA authorization from past and future patients, additional PHI 557 information would be needed, such as patient name and address, which puts additional undo burden on the 558 patient and greatly increases the risk of personal identification. 559 560 Protections Against Risk 561 All members of the research team have been trained in research ethics, confidentiality protection, and HIPAA 562 prior to and throughout the study period through the Program for the Education and Evaluation in Responsible 563 Research and Scholarship (PEERRS) training program at the University of Michigan Medical School. Any 564 additional research personnel must also pass PEERRS certifications. 565 566 All paper data will be held strictly confidential in locked facilities and password protected computers/databases, 567 only accessible by necessary members of the research team. All identifiable data will be stored on the secure 568 and UMHS approved cloud storage, M-Box. The only researcher with access to the identifiable information in 569 M-Box will be Drs.Skolarus, Burke and Feng. A deidentified dataset will be created from the identifiable data 570 and the only researcher with access to this PHI link will be Drs. Skolarus, Burke and Feng. After developing 571 de-identified datasets in the enclave environment, limited analytic datasets will be used for analysis. For all 572 identifiable data collected, the research team will not use them to personally identify a Stroke Ready workshop 573 participant, stroke patient, or Stroke Ready video viewer. Further, none of the secondary outcomes will be 574 linked to the PHI in the primary outcome dataset.

576
The Stroke Ready workshop and materials do not have exclusion criteria, including age limits. This is a no 577 more than minimal risk to the exposure to stroke education or participation in the workshop. We will work with 578 the University of Michigan IRB to ensure that adequate provisions are made. 579 580 Potential Benefits of the Proposed Research to Human Subjects and Others 581 The goal of this project is to provide stroke preparedness education to increase acute stroke treatment. 582 Participants will uniformly gain access to stroke knowledge and education. It is hoped that by increasing 583 knowledge of stroke symptoms and stroke treatments, the community will be more likely to recognize a stroke 584 and call 911 should they see it occur in their community. This will decrease time to hospital arrival and allow us 585 to better care for future victims of stroke. The risks of this protocol are minimal in relation to the potential 586 individual and societal benefits. 587 588 Importance of the Knowledge to be Gained 589 Primarily, this research study aims to increase acute stroke treatments in Flint, MI by providing health 590 education and activities. It will allow us to design a citywide public health education stroke preparedness 591 campaign. The risks of this protocol are minimal in relation to the potential individual and societal benefits of 592 overall stroke education knowledge gain. 593 594 Inclusion of Women and Minorities 595 Given this is a community education intervention no one will be excluded from the community-level 596 interventions. The Stroke Ready campaign should not be harmful to women or minorities. 597 598 Inclusion of Children 599 The Stroke Ready campaign should not be harmful to children as it is adapted from material delivered to youth 600 in the pilot study (HUM00098718).

602
Vulnerable Populations 603 Given this is a community education intervention no one will be excluded from the community-level 604 interventions. The Stroke Ready campaign should not be harmful to vulnerable population. 605

606
Data and Safety Monitoring Plan 607 Because there is a no more than minimal risk in the study, the PIs will provide data and safety oversight. Our 608 local IRB will monitor the research portions of the project. 609 610

Sustainability and dissemination 611
Project sustainability will come through several mechanisms: 1) training of peer leaders who will have 612 knowledge of stroke warning signs and the importance of calling 911; 2) a complete community intervention 613 package that can be administered with little to no training; 3) a well-positioned CAB to promote sustainability; 614 and 4) optimized acute stroke care in a safety net hospital. The products of this application include a strategy 615 to improve acute stroke treatments in safety-net hospitals and an easy to deliver Stroke Ready community 616 intervention to allow for successful of dissemination. If successful, this proposal will directly benefit the Flint 617 community by increasing acute stroke treatment rates thereby decreasing post-stroke disability. Furthermore, it 618 will inform future acute stroke interventions, especially in underserved, predominately African American 619 communities. 620 621 622 623 624 signs review? How many participants engaged in the role play activity? How many reasons for not calling 911 did the peer leaders discuss? How many participants engaged in the review questions at the end of the workshop?

Yes No Explain
Did all participants sign the action plan?
If participants were reluctant to participate in activities, did the leaders gently encourage, but NOT force their participation (even if unsuccessful)?

721
Please answer the following about the peer leader(s). 722

Facilitator/Participation
Strongly Agree Agree Neither Agree/Disagree Disagree Strongly Disagree Facilitator had a professional appearance Facilitator's guide was used for delivery Did the leader leave out or skip over content material provided in the leaders' manual?
Did the facilitator appear knowledgeable?
Did the facilitator appear welcoming?
The facilitator appear to make the workshop more interesting? Thanks so much for participating in Stroke Ready and completing this survey!! 792